Summary of Position

The Manufacturing Technical Writer will work in a dynamic organization in our Noblesville, Indiana location. This role has the responsibility for supporting projects related to Curium’s business strategy in the space of sterile drug manufacturing including reactor and cyclotron derived new products.

Work Schedule: Monday - Friday 8:00am - 4:30pm.

Essential Functions

• Utilize technical writing strategies to ensure content of documentation is clear, concise, and complete.
• Author and revise technical documentation including facility and equipment SOPs, batch records, specifications, and training documents.
• Author and manage change controls as necessary to implement new procedures as well as revisions to documentation and SOPs to facilitate launch of new products.
• Participate in process and equipment testing to learn systems being documented.
• Complete deviations, CAPAs, change controls, document revisions and training activities to meet quality system requirements and timelines.
• Coordinate with operations, R&D, and quality representatives to ensure all project documentation requirements are achieved.

Requirements

• Bachelor's degree or equivalent work experience required.
• Three years of related professional experience preferred.
• Must be able to communicate clearly in English and have solid communication skills including grammar and composition.
• Demonstrated understanding of GMP / cGMP regulations.
• Skill in communication, written and verbal with the ability to interact with cross-functional teams.
• Proven time management skills and a strong attention to detail.
• Proven ability to manage and coordinate multiple projects in a fast-paced, highly professional environment.
• Ability to work well with others and independently.
• Able to read, understand and follow work instructions in a safe, accurate and timely manner.
• Proficiency in computer skills and experience with Microsoft Word, PowerPoint, and Excel.

Working Conditions:

• Standard office environment, willingness to work in a plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Must be willing to wear a variety of personal protective equipment.
• Responsibilities also include the ability to lift, walk, bend, stoop, push, pull, reach, and climb stairs with or without accommodation.
• Must possess good hand-eye coordination.
• May be required to work weekends and holidays to support operations.
• Some gowning may be required to enter laboratory areas.